Search Results

The Peel-Away Introducers are intended to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system.

The Peel-Away introducers provide cardiovascular leads and catheters access to the venous vascular system for cardiac surgery procedures. Peel-Away Introducer sheaths haft. The sheath is the outer component and the dilator fits inside the sheath with the distal end protruding out. A needle, which is connected to the syringe, is used to gain access to the vessel. After blood flow is established, the syringe is removed and a quidewire is inserted through the needle and advanced into the vessel. The assembled sheath/dilator combination is advanced over the guidewire into the vessel. At the proximal end of the sheath is a t-handle hub, which is designed to splitand facilitate the peeling action of the sheath tubing is designed to peel continuously and symmetrically for safe removal of the introducer while maintaining venous access.

This FDA 510(k) summary for the Abbott Medical "Peel-Away Introducer" does not contain the detailed information necessary to answer your questions about acceptance criteria and the study proving the device meets those criteria, as typically found in submissions for AI/ML devices.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Seal Away CS Introducer Kit, K013029) for a traditional medical device (catheter introducer). The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section is very brief and only mentions:

• "The addition of the Exel syringe and modification of the packaging, biocompatibility, and sterilization testing."
• "Completion of all verification and validation activities demonstrated that the syringe meets its predetermined design and performance specifications, and that the peel-away introducer with the new syringe accessory is substantially equivalent to the predicate device."

This type of submission for a conventional device typically relies on design verification and validation testing to ergonomic, material, and functional specifications, rather than a performance study against specific acceptance criteria for a diagnostic or AI/ML device.

Therefore, I cannot provide the specific tables and details you requested. The document does not describe the following aspects which are crucial for AI/ML device evaluations:

• A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, accuracy, etc.)
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

This device is a physical medical instrument (a introducer for catheters), not an AI/ML-driven diagnostic or prognostic tool. Hence, the regulatory submission and the underlying data would not involve AI-specific evaluation methodologies.

Ask a specific question about this device

The Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) facilitating the passage of endoscopes and other instruments into the urinary tract.

The subject device, Peel-Away Introducer, consists of an inner dilator and outer peel-away sheath. The outer sheath fits over the inner dilator and has dual knobs allowing the sheath, manufactured from radiopaque polytetrafluoroethylene (PTFE), to be peeled back and removed. The sheath is manufactured with a length of 32 centimeters. The dilator has an outside diameter of 9, 10, or 12 French, and has a length of 37 centimeters. The 10 French dilator is manufactured from radiopaque polyethylene, while the 9 and 12 French dilators are manufactured from ethylene-vinyl acetate (EVA). The dilator is also tapered 1.2 to 1.5 centimeters from the distal end, depending on its outer diameter, and has a proximal hub composed of polyethylene. The Peel-Away Introducer is supplied sterile and intended for one-time use.

The provided document is a 510(k) Summary for the Cook Incorporated Peel-Away® Introducer. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria, as typically found in comprehensive study reports for AI/software devices.

Instead, it lists the types of performance tests conducted and provides a general statement of compliance. This device is a physical medical instrument (introducer sheath), not an AI/software device, so the requested information about AI model performance metrics, sample sizes for test and training sets, expert adjudication, or MRMC studies is not applicable to this document.

Therefore, I cannot provide the requested information in the format specified for an AI device.

Here's what can be extracted from the document, tailored for a physical device, but acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

Information Not Available in the Document (and why):

2. Sample size used for the test set and the data provenance: Not applicable. For physical devices, typically a certain number of units are manufactured and subjected to physical and chemical testing. The document does not specify the number of units tested or their manufacturing origin beyond being a product of Cook Incorporated.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for physical device performance typically relies on engineering specifications, material science standards, and established testing methodologies, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set: Not applicable. Physical device testing doesn't typically involve adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical introducer, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical introducer, not an AI algorithm.
7. The type of ground truth used: For physical performance tests, the "ground truth" is typically defined by industry standards (e.g., ISO, ASTM, internal engineering specifications) and established by objective measurements and analyses of the device's physical properties and behavior under various conditions. For biocompatibility, it's defined by standards like ISO 10993-1.
8. The sample size for the training set: Not applicable. There is no AI training set for this physical device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for nonvascular use.

The Peel-Away Introducer Set is a single-use, sterile, disposable product that is used to provide initial percutaneous access. It is comprised of a co-axial introducer assembly (peel-away sheath and dilator). Set may contain a wire guide in a size fitted to the endhole of the dilator and may contain an access needle in a gage that allows the included wire guide to pass through its lumen. Additional set components (e.g., luer-slip syringe) are available.

The provided text describes a 510(k) premarket notification for a medical device called the "Peel-Away Introducer Set." This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way an AI/ML device submission would.

Therefore, much of the requested information (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, sample size for training set, and how ground truth for training set was established) is not applicable to this type of device submission as it does not involve AI/ML or diagnostic performance evaluation against a defined ground truth.

However, I can extract the acceptance criteria and reported "performance" in the context of the engineering and biocompatibility tests conducted.

Here's the information that can be extracted or derived:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each of the engineering tests (e.g., number of introducer assemblies, dilators, or wire guides tested). The tests are performed on the device components themselves, not on patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. These are engineering and material tests, not clinical performance or diagnostic studies requiring expert review of a "ground truth" established from patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to clinical or diagnostic study adjudication of patient cases, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an introducer set, not an AI/ML diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering tests, the "ground truth" is defined by established international standards (e.g., BS EN ISO 10993-1:2003, ASTM F6540-12, BS EN ISO 11070: 2014) and predetermined internal criteria for physical properties and material safety.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use.

Cook's Peel-Away® Introducer Sets are single-use, sterile, disposable products that are used to provide initial percutaneous access. They are comprised of a co-axial introducer assembly (peel-away sheath and dilator). Sets may contain a wire guide in a size fitted to the endhole of the dilator and may contain an access needle in a gage that allows the included wire guide to pass through its lumen. Additional set components (e.g., luer-slip syringe, thumb scalpel) are available.

The provided document is a 510(k) premarket notification for a medical device (Peel-Away® Introducer Set). It outlines the device's indications for use, comparison to predicate devices, and technological characteristics, including test results. However, it does not contain information regarding a study that proves the device meets acceptance criteria in the context of an AI/ML powered device. The acceptance criteria and testing described are for the physical properties and biocompatibility of a traditional medical device (catheter introducer set), not for the performance of an algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets them, as this document describes a traditional device submission.

If this was a misunderstanding and you would like me to extract the acceptance criteria and study results for the physical device described in the document, please let me know.

Ask a specific question about this device